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              2016年3月FDA批準銀屑病新藥ixekezumab上市
              2016-04-05 08:13:02 來源:有機化學網 瀏覽:11093

                美國醫藥巨頭禮來(EliLilly)在研的新一代抗炎藥Taltz(ixekizumab)近日在美國監管方面傳來喜訊,FDA已批準Taltz(ixekizumab,80mg/mL)注射液用于適合系統治療(systemictherapy,即全身療治)或光療(phototherapy)的中度至重度斑塊型銀屑病(plaquepsoriasis)成人患者的治療。Taltz不能用于對活性藥物成分ixekizumab或任何輔料有超敏反應(如過敏)的患者。禮來已計劃在第二季度將Taltz推向美國市場。ixekizumab是一種靶向促炎性細胞因子IL-17A的單克隆抗體,IL-17A被認為在多種自身免疫性疾病的炎性反應中發揮關鍵作用。

                Taltz:繼諾華Cosentyx之后上市的第2款IL-17A單抗抗炎藥

                此次批準,使Taltz成為繼諾華重磅抗炎藥Cosentyx(secukinumab)之后,在美國獲批上市的第二款IL-17A單抗藥物。業界對Taltz十分看好,如果該藥第二個適應癥——銀屑病關節炎(PsA)也成功獲批,其年銷售峰值將突破10億美元。之前,諾華Cosentyx已在美國和歐盟獲批治療斑塊型銀屑病、銀屑病關節炎(PsA)、強直性脊柱炎(AS)。在歐盟方面,Taltz于今年2月底獲CHMP支持批準的積極意見,預計將在今年5月獲得歐盟委員會(EC)批準,成為歐洲上市的第二款IL-17A單抗藥物。

                然而,有分析師指出,該市場將很快迎來其他競爭產品,默沙東的MK-3222及強生(JNJ)的IL-23阻斷劑guselkumab已進入III期臨床開發;另一方面,在安進放棄與阿斯利康聯合開發IL-17A單抗brodalumab之后,醫藥界出了名的收購狂Valeant出資$4.45億買進brodalumab,目前正在迅速推進該藥的臨床開發。

                當前,銀屑病市場由TNF阻斷劑(抗腫瘤壞死因子單抗)統治,然而有高達40%的患者對TNF阻斷劑治療不足或無反應。而IL-17單抗抗炎藥的上市,將極大地改善銀屑病、銀屑病關節炎及其他炎癥性疾病的臨床標準護理。

                Taltz:大型III期臨床項目擊敗安進超級重磅抗炎藥恩利(Enbrel)

                Taltz的獲批,是基于在中度至重度斑塊型銀屑病群體中開展的迄今為止最大規模的III期臨床項目。該項目包括3個雙盲、多中心III期研究(UNCOVER-1,-2,-3),涉及21個國家超過3800例中度至重度斑塊型銀屑病成人患者,研究結果證明了ixekizumab的療效和安全性。這3個研究評估了ixekizumab(起始給藥劑量160mg,之后每2周給藥劑量80mg)相比安慰劑治療12周的療效和安全性,其中,UNCOVER-2研究和UNCOVER-3研究還納入了一組額外的對照組,該對照組中患者接受依那西普(etanercept,50mg,每周2次)治療12周。該項目3個研究的安全性和療效,將進一步評估直至60周。

                研究結果顯示,這3個關鍵性研究均達到研究的所有主要終點和關鍵次要終點,ixekizumab在各項皮損消退指標上均優于安進的重磅抗炎藥Enbrel(恩利,通用名:etanercept,依那西普)和安慰劑,數據具有統計學顯著性。這些數據對于罹患中度至重度斑塊型銀屑病的患者而言具有重要意義,Taltz的獲批上市,將幫助更多的銀屑病患者的病情獲得全面緩解。

                關于Taltz(ixekizumab):

                ixekizumab是一種單克隆抗體,針對具有促炎作用的細胞因子白介素-17A(IL-17A)具有較高的親和力和特異性,可抑制IL-17A與IL-17受體的結合。對于銀屑病患者而言,IL-17A在驅動角化細胞(皮膚細胞)過度增殖和活化方面發揮了重要作用。ixekizumab不會與細胞因子IL-17B、IL-17C、IL-17D、IL-17E或IL-17F相結合。Ixekizumab通過皮下注射給藥。目前,禮來也正在推進ixekizumab治療銀屑病關節炎及其他炎癥性疾病的相關臨床研究。

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